Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Product description
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
Lot numbers, UPCs & expiration codes
Lot #: M300442, Exp Date: 6/30/2025
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0377-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 10, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 2724 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0377-2025, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 96681
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot #: M300442, Exp Date: 6/30/2025
- Postal code
- 34108-2755
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0377-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 2724 bottles
- Termination date
- Jan 5, 2026
- Reason for recall
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
- Distribution pattern
- USA nationwide
- Recall initiation date
- Apr 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2025